Mouthpiece, nasal seal, head appliance, apparatus, and methods of treating sleep apnea

ABSTRACT

A CPAP device and a method for treating sleep apnea use a head appliance with an oral adaptor comprising a tube partially inserted in a person&#39;s mouth and a diaphragm applied over the tube against the mouth, such that the lips are formed into a tight seal with the tube. A nasal seal is described comprising two rollers to which a strap is attached, so that the nasal seal is easily put in place, adjusted and maintained by rolling the rollers on the nose sides or pulling the straps.

BACKGROUND

Sleep apnea is a common sleep ailment that affects as many as fivepercent of the population worldwide. Persons with sleep apnea stopbreathing for short durations many times during sleep, so that the depthand quality of their sleep is reduced. As a result, persons with sleepapnea suffer from a profound sleepiness, which can impair their abilityand performance at work and in other activities.

Sleep apnea often results from a collapse of the person's throat tissuesduring sleep, which reduces or suppresses the air flow to the lungs.Lowered oxygen levels and increased carbon dioxide levels in blood alertthe person's brain and breathing resumes, but each occurrence arousesthe person and interrupts restorative sleep.

Surgery is a possible treatment but surgical procedures are complex andsuccess rates are often low. A more common treatment for sleep apnea isto force air inside the person's throat during sleep with a respiratorapparatus. Apparatuses of this type use continuous positive airwaypressure or CPAP.

Respirator apparatuses traditionally provide pressurized air or gas to anasal mask which is applied to the persons' nose during sleep. However,nasal masks are difficult to apply on a person's nose, which results inskin irritation, nasal congestion, airways dryness, and air leaks. Inaddition, nasal masks are bulky, so that the person wearing the maskcannot move easily and may experience claustrophobia.

SUMMARY OF THE INVENTION

In view of the above, there is a need for an apparatus allowing a personhaving sleep apnea to breathe regularly without interruption duringsleep, which is easy and comfortable to wear, does not leakunintentionally, and effectively maintains the open state of theairways.

The present invention provides such an apparatus. In particular, thepresent invention provides an oral adaptor or mouthpiece that allows arespirator to apply positive pressure in a person's airways withoutleaks and without irritation or congestion, and a nasal seal or sealthat is easy and comfortable to wear and effectively avoidsunintentional leaks. The present invention also provides a headappliance that includes such a mouthpiece and a nasal seal, as well asan apparatus and method for treating sleep apnea or symptoms of sleepapnea.

In an aspect of the present invention, an oral adaptor for a CPAP(Continuous Positive Airway Pressure) device comprises: an oral inserthaving a passage therein, comprising an insertion portion to be insertedinto a person's mouth and a connection portion for connecting the oralinsert to a CPAP respirator, and a sealing element to be placed on theperson's mouth, wherein the sealing element is a flexible material suchthat the person's lips form a seal on the oral insert. In someembodiments, the sealing element can be a diaphragm or a pad.

In another aspect of the present invention, an oral adaptor to beapplied to a person's mouth comprises: a tubular portion having aninsertion end to be inserted in a person's mouth and a connection end tobe connected to a source of positive pressure, and a first surface whichfaces an inner side of a person's lips, and a second surface which facesan outer side of the person's lips, when the oral adaptor is applied tothe person's mouth, such that the person's lips are conformed betweenthe second surface and at least one of the tubular portion and the firstsurface when a positive pressure is created inside the mouth to form aseal with the oral adaptor.

In another aspect of the present invention, a nasal seal for a CPAPdevice comprises two curved pieces to be placed on respective sides of aperson's nose, which are connected to each other so as to leave a spacebetween the curved pieces for the person's nose, wherein a holding strapis attached to the nasal seal for application on the person's nose. Inone embodiment, the curved pieces are rollers rotatable aroundrespective axes, the axes being connected to each other so as to leave aspace between the rollers for the person's nose.

In another aspect of the present invention, a head appliance comprisesan oral adaptor or a mouthpiece as described above, a nasal seal asdescribed above, or both.

In another aspect of the present invention, a head appliance for a CPAPdevice comprises: a mouthpiece having an insertion portion to beinserted in a person's mouth and a connection portion to be connected toa CPAP respirator, a connection tube having an end connected to theconnection portion of the mouthpiece, a head strap to be placed over apersons' head, and a tube support element attached to the head strap forsupporting the connection tube.

In yet another aspect of the present invention, a CPAP device comprisesa head appliance as described above connected to a CPAP respirator.

In a further aspect of the present invention, a method for treatingsymptoms of sleep apnea in a person comprises: inserting an insertionportion of an oral insert in the person's mouth, applying a sealingelement on the person's mouth so that the person's lips form a tightseal around the insertion portion of the oral insert, and connecting theoral insert to a source of positive pressure.

In another aspect of the present invention, a method for treatingsymptoms of sleep apnea in a person comprises: inserting an insertionportion of an oral insert in the person's mouth such that a firstsurface of the insertion portion faces an inner side of the person'slips, applying a sealing element on the person's mouth such that asecond surface faces an outer side of the person's lips, so that thelips form a tight seal around the insertion portion of the oral insert,and connecting the oral insert to a source of positive pressure.

In various embodiments, advantages of the present invention may include:the smaller overall size of the head gear, which facilitates movementsof the sleeper, the absence of nasal CPAP, which reduces airwaysirritation and congestion, the reduction or elimination of unintentionalleaks, which avoids airways dryness and improves efficiency, the ease ofapplication of the head gear and the softness of the contact between theelements of the head gear and the skin, which makes wearing the headgear more comfortable. The nasal seal is able to be removed easily. Inparticular, the present invention can make it possible to essentiallyeliminate unintentional leaks.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a front view of a first embodiment of a head applianceaccording to the present invention mounted on a person's head;

FIG. 2 is a side view of the head appliance of FIG. 1;

FIG. 3A is a vertical cross-sectional view of the head appliance of FIG.1 along line 3—3 of FIG. 1;

FIG. 3B is a horizontal cross-sectional view of an oral adaptor of thehead appliance along line B—B of FIG. 3A;

FIG. 3C is a perspective view of the oral adaptor of FIG. 3B;

FIG. 3D is a view of the oral adaptor of FIG. 3B along arrow D on FIG.3B;

FIG. 3E is a schematic partial vertical cross-sectional view of the headappliance of FIG. 1 along line 3—3 of FIG. 1 without a diaphragm to showlip positions;

FIG. 4 is a side view of a second embodiment of a head applianceaccording to the present invention, further comprising a jaw strapmounted on the person's head;

FIG. 5 is a front view of a third embodiment of a head applianceaccording to the present invention, further comprising a nasal sealmounted on the person's head;

FIG. 6 is a side view of the head appliance of FIG. 5;

FIG. 7 is a side view of a fourth embodiment of a head applianceaccording to the present invention, further comprising a head strap anda connection tube;

FIG. 8 is a front view of the head appliance of FIG. 7;

FIG. 9A is a partial perspective view of the nasal seal of FIG. 7;

FIG. 9B is a schematic partial horizontal cross-sectional view of thehead appliance of FIG. 7 along line 9—9 on FIG. 8 showing thepositioning of the nasal seal on the nose;

FIG. 10 is a schematic view of a CPAP apparatus connected to the headappliance of FIG. 7;

FIG. 11 is a front view of a fifth embodiment of a head applianceaccording to the present invention without a lower diaphragm supportstrap;

FIG. 12 is a side view of the head appliance of FIG. 11;

FIG. 13 is a cross-section al view of the head appliance of FIG. 11along line 13—13 of FIG. 11;

FIG. 14 is a front view of the head appliance of FIG. 11 with the lowerdiaphragm support strap;

FIG. 15 is a side view of the head appliance of FIG. 11 with the lowerdiaphragm support strap;

FIG. 16 is a side view of a sixth embodiment of a head applianceaccording to the present invention, further comprising a nasal seal;

FIG. 17 is a front view of the head appliance of FIG. 16;

FIG. 18 is a side view of a seventh embodiment of a head applianceaccording to the present invention, further comprising a nasal seal;

FIG. 19 is a front view of the head appliance of FIG. 18;

FIG. 20 is a front view of an eighth embodiment of a head applianceaccording to the present invention, further comprising a connecting hosesupport;

FIG. 21 is a side view of the head appliance of FIG. 20;

FIG. 22 is a front view of a ninth embodiment of a head applianceaccording to the present invention, further comprising pressure elementsand a jaw strap, shown without a jaw strap;

FIG. 23 is a front view of the head appliance of FIG. 22, shown with thejaw strap;

FIG. 24 is a side view of the head appliance of FIG. 23;

FIG. 25 is a front view of a tenth embodiment of a head applianceaccording to the present invention, further comprising a tube holdingstrap;

FIG. 26 is a side view of the head appliance of FIG. 25;

FIG. 27 is a front view of an eleventh embodiment of a head applianceaccording to the present invention, further comprising a nasal seal anda connecting hose support; and

FIG. 28 is a side view of the head appliance of FIG. 27.

DESCRIPTION OF PARTICULAR EMBODIMENTS

FIGS. 1-3 show a first embodiment of a head appliance for a CPAP deviceaccording to the present invention, which is mounted on a person's head.The head appliance comprises an oral adaptor 1, which is applied as amouthpiece to the mouth of the person. The oral adaptor 1 is partiallyinserted into the person's mouth and is maintained against the person'smouth by a first strap2 and a second strap 3 passed around the person'shead.

The oral adaptor comprises a tube 4, which defines a passage 5 for airor gas having an opening 6 inside the mouth and an opening 7 outside themouth. The tube has the general shape of an L. One branch of the L formsan insertion portion 8 that is inserted into the person's mouth. Theother branch of the L defines a connection portion 9 for connecting theoral adaptor to an air or gas supply hose of an apparatus for applying apositive pressure to the airways by means of pressurized air or gas.Also, an exhaust port is located on the tube or between the tube and theapparatus for applying a positive pressure. In this embodiment, the oraladaptor is connected to the supply hose by a snapped connection, whichmakes it easy to connect and disconnect the oral adaptor to the supplyhose. The insertion portion 8 carries a peripheral flange 12, which ispositioned between the teeth (not shown) and the inner sides of theperson's lips. Thus, the inner sides of the lips face a surface 13 ofthe peripheral flange that is oriented toward the corner of the L shape.The peripheral flange 12 has substantially a butterfly shape in thisembodiment and the insertion portion 8 of the tube has an oval shape inthe area where it meets the peripheral flange. Further, the flange 12 isadvantageously dimensioned so as to fill the space between the lips andthe teeth and gums around the mouth, and the outer edge of the flange istapered, rounded, or both tapered and rounded, so as to protect theadjacent mouth tissues and to improve the sealing effect of the innerlips against the flange.

At least one biting bit 14 is located at the inner end of the insertionportion to aid positioning of the oral adaptor in the mouth. Forexample, two biting bits, each having a mushroom shape, are attached atthe inner surface of the peripheral flange 12 on the sides of the air orgas passage as shown on FIG. 3. An oral insert comprising a tube with aflange and biting bits is sold for example as part of a snorkel underthe mark AIR DRY by the TECHNISUB company. Advantageously, the bitingbit heads have rectangular shapes and extend to the outer periphery ofthe flange on each side, and the biting bit leg has dimples that allowthe teeth to grip it.

In a variant (shown only in FIG. 3B), an exhaust port 92 is located on atube section branched on the tube of the oral adaptor, for example inthe area of the L corner. In that case, the oral adaptor can havesubstantially a T shape. One branch of the T defines the insertionportion and a second branch of the T defines a connection portion forconnecting the oral adaptor to the apparatus for applying a positivepressure, as in the tube having a L shape. However, in this variant, theexhaust port is located on the third branch of the T. This variantreduces the amount of expelled carbon dioxide that returns to the mouthupon inhalation.

On the outer side of the lips is applied a sealing element in the formof a diaphragm 15. The diaphragm 15 is large enough so as to completelycover the mouth and the lips from the outside. In this embodiment, thediaphragm 15 extends beyond the outer limit of the lips. The diaphragmis made of flexible material so that its shape conforms itself to theshape of the outer side of the lips when the diaphragm is applied to thelips. The diaphragm has a hole 16 for passing it over the tube.Preferably, the hole 16 has a shape and dimension equal to or less thanthose of a cross-section of the tube 4 at the location of the lips, sothat a tight fit is provided between the diaphragm 15 and the tube 4when the diaphragm is applied to the lips. The diaphragm is separatefrom the tube. In the alternative, the diaphragm could be integral with(such as by molding) or attached to the tube, for example by a glue,tape or staple connection, although care should be taken to avoidconfigurations that unduly irritate the skin.

Advantageously, the diaphragm 15 is less rigid than the peripheralflange 12 on the insertion portion 8 of the tube 4. Thus, the inner sideof the lips is applied against the surface of the peripheral flange 12when the insertion portion is positioned inside the mouth, and the outerside of the lips is firmly maintained without excessive pressure by thediaphragm 15 covering the mouth. As a result, the lips form a tight sealwithout leak against the tube 4, or at least between the peripheralflange 12 and the diaphragm 15. An even tighter seal is obtained byapplication of petroleum jelly or like substance in the space betweenthe peripheral flange and the diaphragm where the lips surround the tube4, on the tube itself, and/or on the lips, or by the secretion of salivain these locations.

Preferably, the diaphragm is elastic, so that the diaphragm can stretchand/or contract to an appropriate degree before, during and/or afterpositioning of the diaphragm on the lips in order to obtain a tighterseal with the lips, or with the skin around the lips. For example, thediaphragm can be positioned over the lips and pulled by its sides toextend the elastic material, and then allowed to contract. For thepresent purposes, elastic materials are defined as materials that, whenstretched 10% (more preferably 50%), for one hour, in a direction, atroom temperature, experience less than 5% permanent deformation afterthe stress is removed. In a preferred embodiment, the elastic materialcomprises latex. It has been discovered that an elastic diaphragmresults in a superior seal as compared to an inelastic diaphragm.Preferred materials for the diaphragm are non-porous, elastic materialsthat do not irritate the skin, for example natural rubber latex sold asunder the mark THERABAND.

The first strap 2 maintains the tube in its position applied to themouth. The first strap is attached to the tube 4 and passes around theperson's head above the ears. Advantageously, the first strap 2 isattached to the tube 4 at a location as close as possible to the mouth,in particular, closer to the insertion portion than to an end of theoral insert opposed to the insertion portion, so that the insertionportion 8 is pulled by the strap toward the upper teeth while avoiding alever effect which would pull the insertion portion 8 away from thebottom teeth. Also, the biting bit or bits 14 are maintained in contactwith the upper teeth. At least one end of the first strap is attached tothe tube 4 on the branch of the L shape which carries the insertionportion 8, i.e., closer to the insertion portion 8 than to the oppositeend of the tube. The other end of the first strap 2 can be attached tothe same location, or to the other branch of the L shape, which carriesthe connection portion 9, as shown on FIG. 1. Thus, the first strapconstitutes a tube holding strap.

The second strap 3 passes around the person's head under the ears andmaintains the diaphragm 15 against the outer side of the lips. Thesecond strap 3 is not attached to the diaphragm 15, but comprises anenlarged portion 17 with a hole 18, which is passed over the tube 4 andapplied against the diaphragm 15 to maintain the diaphragm against thelips. Thus, the second strap constitutes a diaphragm strap. The enlargedportion 17 of the second strap is advantageously flexible or elastic soas to conform itself to the shape of the diaphragm, i.e., to the shapeof the outer side of the lips. However, the enlarged portion 17 can beof a less flexible or less elastic material than the diaphragm, providedthe enlarged portion is flexible enough to maintain the diaphragmagainst the lips so as to avoid leaks. In an alternative embodiment, thesecond strap could be attached to the diaphragm, for example, by tapingthe diaphragm to the strap.

The enlarged portion of the second strap applies the diaphragm againstthe lips with a weak force that is intended to be sufficient tocompensate forces tending to pull the insertion portion away from themouth without compressing the mouth to a level which would damage thelips, gums or teeth, or other parts of the mouth. More specifically, thesecond strap applies forces 19 and 20 that are directed so as to pushthe lips toward the flange 12 and toward the tube 4, with the forcecomponent directed toward the tube (vertical component on FIG. 3E) iscomparable to the force component directed toward the flange (horizontalcomponent on FIG. 3E). In the case of an elastic diaphragm, the forcesare preferably sufficient to maintain the diaphragm in an appropriatelyextended state, so as to obtain a tight seal with the lips or with theskin around the lips.

In a variant of this embodiment, the diaphragm could be integral with orattached permanently or removably to the second strap. However, in thepresent embodiment, the diaphragm extends above and below the enlargedportion of the second strap to facilitate positioning and applicationover the lips without folds or creases, and, in the case of an elasticdiaphragm, to facilitate pulling the sides of the diaphragm in order toobtain a tighter seal.

Each strap has a ribbon shape and is adjustable in length, for example,by elasticity or with Velcro® (hooks and loops), with a buckle, with anelastic portion, with buttons, or combinations of these. It is notedthat several variants are possible for the straps other than the onesdescribed above. Thus, in alternative embodiments, each or both of thefirst strap and second strap are attached to a part of the oral adaptoror are separate from the oral adaptor, only one strap or more than twostraps are provided, or the oral adaptor is held between the person'slips without any strap. Each of the straps may be elastic or comprise anelastic portion, or it may have a length that does not vary betweenadjustments. Suitable materials for the straps or portions of the strapsinclude, but are not limited to, fabric, flexible material, for exampleplastic, and an elastic material such as rubber.

FIG. 4 shows a second embodiment of a head appliance according to thepresent invention, which is identical to the head appliance of FIGS. 1-3except that a jaw strap 21 is provided around the person's head over thefirst and second straps. The jaw strap 21 has a ribbon shape and passesabove the ears and over the chin. In the area of the chin, the jaw strapis divided in two segments 22 and 23, one above a central part of thechin, the other under a central part of the chin, so that the centralpart of the chin is not covered by the jaw strap.

An advantage of the jaw strap 21 is that it prevents the lower jaw fromdropping excessively, as occurs for some persons when they sleep, whichcould create leaks. The jaw strap can also help in maintaining thediaphragm by pressing its lower portion against the person's skin underthe mouth. Additionally, the jaw strap passes over the cheeks, so as toprevent ballooning of the cheeks, which could loosen the lips fromaround the tube. Thus, the jaw strap complements the other straps, inparticular the second strap, which may prevent ballooning of tissuearound the lips. In the alternative, the jaw strap could be provided tofulfill only some of these objectives.

In addition, at least one pressure element or portion 24 (shown indotted line on FIG. 4) is located on the person's face over the cheeksbeyond the location facing the extremities of the peripheral flange, forexample at opposite ends of the diaphragm or under one of the straps. Ina preferred embodiment, there is a larger peripheral flange so that thesealing elements do not extend beyond the location facing theextremities of the flange. The pressure portions 24 are pressed by thestrap or straps against the cheeks and tend to push the cheeks inward,which improves the seal formed by the lips between the peripheral flange12 and the diaphragm 15 and between the tube 4 and the diaphragm 15. Thepressure portions 24 may be unattached or attached to another part ofthe device, for example the diaphragm or one of the straps, for examplethe diaphragm strap 3 or the jaw strap 17.

FIGS. 5-6 show a third embodiment of a head appliance according to thepresent invention, which is identical to the head appliance of FIG. 4except that a nasal seal 25 is provided on the person's nose. The nasalseal is applied to both sides of the nose to close the nostrils and ismaintained by a nasal seal strap 26 that passes around the person'shead.

An embodiment of a nasal seal is shown in more detail in FIG. 9. Itcomprises two curved pieces 27 and 28 disposed at a distance from eachother. In the embodiment described in the figures, the curved pieces arerollers rotatable around axes, which are connected at their ends by atleast one connection member, preferably elastic members 29 and 30, sothat an adjustable space for the nose is defined between the rollers. Ina variant, each of the cylinders has an aperture therethrough, and theelastic connection comprises an elastic band that moves through theaperture in each cylinder. The rollers are preferably made or compriseat least a layer or a portion of a flexible material, for example anelastic material. Advantageously, the ends of the nasal strap areconnected to the rollers such that the rollers are rotated in oppositedirection when the nasal strap is pulled, as shown by the upper arrows31 and 32 on FIG. 9B.

The rollers close the nostrils primarily by applying shear forces to theskin next to the base of the nose, which tends to pull the skin next tothe nose on both sides of the nose toward the base of the nose, as shownby the lower arrows 33 and 34 on FIG. 9B. In other words, the rollersare located in the corners formed by the nose faces and the skinadjacent to the nose base without directly pressing on the nose itself.Thus, a perfect seal can be obtained without any compressive force onthe nose itself, which protects the fragile skin of the nose from beingdamaged when the nasal seal is applied for long periods of time, forexample, a full night. In a variant, the rollers secondarily apply aslight compressive force to a region of the nose closer to the tip asshown by the middle arrows 35 and 36 on FIG. 9B, so as to close thenostrils in that region. In another variant, the rollers are locatedagainst the nose faces and apply a compressive force appropriate toclose the nostrils so as to obtain an airtight seal. In that case, thenasal seal can be applied against the nose faces without touching thebase of the nose. Any remaining opening can be filled with petroleumjelly so as to obtain a perfect seal.

The nasal strap 26 helps obtain or maintain a good positioning of therollers 27 and 28 against the nose because if the rollers are moved awayfrom the person's face, the strap pulls the rollers, which tends to makethem roll toward the face. As a result, a tight seal is obtained withoutapplying a strong force on the nose or around the head. For example, asshown on FIG. 9A, the strap ends are connected to and rolled around theperipheral surface of the rollers. The nasal strap can have featuressimilar to the other straps described above. The strap ends arepreferably a soft material 37 that does not irritate the skin.

The proper balance between forces, i.e., to obtain high shear force andlow compressive force, is obtained by adjusting one of several of (a)the circumference of the rollers, (b) the cleanliness of the face (nogreasiness), (c) the nature of the roller surface (high coefficient offriction), (d) the size and elastic properties of the elastic members,(e) the elastic properties of the holding strap, and (f) the amount oftension of the holding strap.

FIGS. 7 and 8 show a fourth embodiment of a head appliance according tothe present invention, which is identical to the head appliance of FIGS.5-6 except that it additionally comprises a connection hose 38 connectedto the tube 4 of the oral adaptor 1 for connecting the head appliance tothe source of positive air or gas pressure or to a respirator. Theconnection hose 38 is preferably made of a flexible or elastic materialand able to change shape, so that movements of the person's head are notprevented, but is sufficiently rigid to maintain a passage for air orgas from the respirator, in particular when it is submitted to radial ortorsional forces. Advantageously, the oral adaptor can freely rotatewith respect to the connection hose.

A head band 39 passes around the person's head above the ears and theface. A hose support 40 is attached to the head band on the same side ofthe head as the connection portion of the oral adaptor. The hose supportis in the shape of an open or closed ring that defines a passage 41 forthe connection hose. The connection hose can slide and rotate inside thering. However, in the case of an open ring, the diameter of theconnection hose is larger than the width of the cut portion of the ring,so that the connection hose cannot be removed through the cut portion ofthe ring, except by collapsing the hose or by widening the cut portionof the ring when the ring is not completely rigid. The head band is, forexample, a conventional elastic head band, and the hose support is, forexample, a snorkel hose support from a snorkel sold under the mark AIRDRY by the TECHNISUB company.

The exhalation port is mounted on the connection portion of the oraladaptor between the tube and the connection hose. For example, theexhalation port is located on a connection section which is freelyrotatable with respect to at least one of the oral adaptor and theconnection hose for the CPAP respirator. In a variant not shown, theexhalation port could be located on a branched passage opening in thepassage between the insertion portion and the connection portion. Theexhalation port allows expired air to exit the passage but prevents airfrom the outside to penetrate into the passage. A suitable exhalationport (for example, 10, 11 in FIG. 1) is sold for example under the markWHISPER SWIVEL by the RESPIRONICS company.

FIG. 10 shows schematically an embodiment of a respirator 42 that isconnected to a head appliance according to the present invention toprovide a source of positive pressure. The respirator comprises a CPAPdevice 43 that creates positive pressure. The respirator is operatedwith electric power through an electric wire 44 which may be plugged toa power outlet (not shown). The respirator provides a positive pressureto an outlet 45. A suitable respirator is for example the CPAP machinesold under the RESPIRONICS mark.

An end of a first hose 46 is connected to the outlet of the CPAP. Thus,positive air or gas pressure is created inside the first hose. Ahumidifier 47 has an inlet 48 connected to the other end of the firsthose and an outlet 49 connected to an end of a second hose 50. Thus, airor gas having positive pressure and adjusted humidity content is presentin the second hose. The second hose supplies air or gas to theconnection hose of the head appliance or directly to the exhalationport, or the second hose constitute the connection hose. Given theabsence of unintentional leaks, the humidifier can be omitted unless theperson desires additional humidification of the inhaled air or gas.

The head appliance according to the above embodiments is advantageouslypositioned on the person's head as follows.

As a preliminary step, the person can apply petroleum jelly or the likein the nostrils and lip balm on the inner part of the outer lips. Theperson then prepares the insertion portion by passing the diaphragm overthe tube, through the diaphragm hole, in the case of an unattacheddiaphragm.

Next, as a first positioning step, the person inserts the insertionportion of the oral adaptor into her mouth with the peripheral flangebetween the teeth and the lips, and places her lips around the tube.

Second, the person extends the diaphragm over the lips without folds orcreases, and passes the tube holding strap around the head above theears to retain the insertion portion against the upper teeth.

Third, the person passes the diaphragm strap over the tube and adjustsit around the head under the ears and over the diaphragm above and underthe tube to maintain the diaphragm over the lips while forming the lipsagainst the flange and the tube of the oral adaptor. In the case of anelastic diaphragm, the person advantageously pulls the sides or thecorners of the diaphragm so as to extend it over the lips to obtain atighter seal.

Fourth, the person places pressure elements in appropriate locations, ifdesired, then passes the jaw strap over the chin, the cheeks, and aroundthe head above the ears, if a jaw strap is provided.

Fifth, the person puts on the nasal seal, if provided, by placing therollers against the facial skin adjacent to the nose, against the skinof the nose faces, or both, and by rotating the rollers toward the faceand/or pulling the strap to rotate the rollers. As a result, the rollersroll on the skin toward the nose base and are pulled toward each otherby the elastic members until the nostrils are totally collapsed. Byadjusting the tension of the strap before or after positioning therollers, an adequate shear force can be applied by the rollers againstthe facial skin or the nose sides to maintain a secure seal withoutexcessive compressive force against the nose.

Sixth, the person connects the oral adaptor to the air or gas supplyhose of the respirator. When positive pressure is applied inside themouth, the lips are further molded and wedged against the tube betweenthe peripheral flange and the diaphragm. As a result, a secure seal canbe obtained in the area of the mouth also. In the case of an elasticdiaphragm, a better seal may be obtained if the diaphragm, a better sealcan be obtained if the diaphragm is again adjusted, as discussed abovein the third step. If provided, the connection hose is connected betweenthe oral adaptor and the air or gas supply hose and positioned in thehose support of the head band, which is placed around the head.

FIGS. 11-15 show a fifth embodiment of a head appliance according to thepresent invention. In this embodiment also, the head appliance comprisesan oral adaptor. The oral adaptor comprises a tube and a diaphragm thatare substantially similar to the tube and diaphragm of the first tofourth embodiments. However, this fifth embodiment is different from thefirst to fourth embodiments in particular in that a pad 51 that isdimensioned so as to cover the person's lips is applied over thediaphragm. The pad is made of a relatively thick layer of flexible andresilient or elastic material, for example a rubber foam. The inner face52 of the pad can cover the diaphragm partially or completely as shownon FIG. 13.

As in previous embodiments, the diaphragm can be unattached, integral,or attached permanently or removably to the tube. Further, the headappliance comprises straps for supporting the tube and maintaining thediaphragm. The tube holding strap 53 is substantially identical to thefirst strap in the first to fourth embodiments. However, the otherstraps may be different from the other straps in the first to fourthembodiments. For example, the single diaphragm strap is replaced by anupper diaphragm strap 54 and a lower diaphragm strap 55. The lowerdiaphragm strap is shown on FIGS. 14-15 but not on FIGS. 11-13.

The upper diaphragm strap 54 is in the form of a band that surrounds thehead under the ears and is applied on an upper portion of the sealingpad 51 above the tube, i.e., over and above the upper lip but under thenose. The lower diaphragm strap 55 is in the form of a band thatsurrounds the head above the ears and is applied on a lower portion ofthe sealing element 51 under the tube, i.e., over and under the lowerlip, and above or over at least a portion of the chin. Thus, the upperdiaphragm strap 54 maintains the upper portion of the diaphragm againstthe upper lip and the lower diaphragm strap 55 maintains the lowerportion of the diaphragm against the lower lip. The lower diaphragmstrap 55 can also function as a jaw strap to maintain the mouth closedduring sleep, avoid ballooning of the cheeks, and apply pressureportions (not shown) on the lip edges or on the cheeks.

A suitable upper diaphragm strap is sold for example as SNUG FIT model“chin strap” by MALLINCKRODT company, and a suitable lower diaphragmstrap is sold as CHIN STRAP model under the mark RESPIRONICS.

In this embodiment, the pad participates in distributing, equalizing, orboth, the forces exerted by the upper and lower diaphragm support strapsto the diaphragm, so as to improve the seal between the diaphragm andthe lips or the skin around the lips, while protecting the skin againstexcessive localized pressure. Thus, the inner face 52 of the pad may becontoured so as to have a shape corresponding to the shape of a person'slips, for example with a central recess which can be positioned over thelips.

FIGS. 16-17 show a sixth embodiment of the head appliance according tothe present invention. In this sixth embodiment, the head appliance isidentical to the head appliance of the fifth embodiment except that itadditionally comprises a nasal seal. The nasal seal is identical to thenasal seal in the third and fourth embodiments.

FIGS. 18-19 show a seventh embodiment of the head appliance according tothe present invention, in which the head appliance is identical to thehead appliance of the sixth embodiment except that it additionallycomprises a connection hose with head band and hose support, which aresubstantially identical to those of the fourth embodiment.

In variants of the embodiments of FIGS. 11-19, as in other embodimentsof the present invention, the diaphragm extends advantageously below andunder the maintaining elements such as straps or pads, so as to allowadjustment of the diaphragm to avoid leaks. The diaphragm isadvantageously rectangular or oval in shape with dimensions adapted toextend beyond the mouth on each side.

The head appliance according to the fifth to seventh embodiments of thepresent invention is positioned on the person's head as follows.

First, the person places the insertion portion of the oral insert intoher mouth with the peripheral flange between the teeth and the lips, andplaces the lips around the tube. This operation is facilitated when theperson bites into the biting bits.

Second, the person fully extends the diaphragm over the mouth, thenpasses the tube holding strap around the head above the ears to pull theinsertion portion against the upper teeth.

Third, the person positions the pad over the diaphragm, then places theupper diaphragm strap, for example by passing the strap around her headbelow the ears, and fastens it over the upper portion of the pad underher nose.

Fourth, the person places the lower diaphragm strap, for example bypassing over the lower part of the pad and over the ears, then fasteningit at the top of her head. As a result, the straps cooperate to keep thepad in place, so that the diaphragm is maintained against the lips butis prevented from separation from the respective lips by the pad and thestraps. The actual force applied by the straps can be very low, i.e.,just sufficient to maintain the pad, and additional pressure portions ifprovided, in place against the face.

Fifth and sixth, the person then puts on the nasal seal and the headband, if provided, and connects the connection hose or the supply hoseto the oral adaptor. Once a positive pressure is created within theairways, the nasal seal can be readjusted, and the lips moved againstthe diaphragm to obtain a perfect seal around the tube with zero leaks.Advantageously, the lips are expanded and moved outward to contact thediaphragm, so that only lip tissue, not skin tissue, contact thediaphragm.

FIGS. 20-28 show additional embodiments of head appliances according tothe present invention, which is substantially similar to the first tofourth embodiments except that the diaphragm is maintained over the lipsby respective upper and lower diaphragm straps 56 and 57 passing aroundthe back of the person's neck, under the ears, and over the diaphragmabove and under, respectively, the tube of the oral adaptor. Further, ajaw strap 58 and a tube holding strap 59, which are shown respectivelyon FIGS. 23-26 and 27-28, are additionally provided around the person'shead. Additional pressure portions are provided over the sides of thelips or adjacent skin tissues, i.e., a first pressure portion 60 underthe connection portion of the tube and a second pressure portion 61between the upper and lower diaphragm straps on the side of the oraladaptor opposed to the connection portion. Further, in this embodiment,a third pressure portion 62 is applied on the second pressure portion61. The jaw strap is applied over at least one of these pressureportions, here, the second and third pressure portions. The tube holdingstrap is applied over the connection portion 9 of the tube of the oraladaptor, i.e., over the first pressure portion.

Thus, the diaphragm is maintained over the lips by the upper and lowerdiaphragm straps 56 and 57, the mouth is kept closed by the jaw strap58, and the oral adaptor is held by the tube holding strap 59, whileballooning effects and corresponding leaks are avoided by the jaw strap58 and the pressure portions 60-62 on the mouth edges or on the cheeks.

In any of the embodiments shown in the figures, the tube of the oraladaptor has the connection portion on the left side of the person'sface. It will be immediately apparent that the connection portion couldalso be located on the right side, or in front of the person's mouth,the connection hose passing for example around the person's nose. Also,the oral adaptor could have two connection portions on each side of theperson's face, which could be connected alternatively to a connectionhose and a seal, or connected simultaneously to a connection hose havinga double connection end passing for example over the person's face. Inthe alternative, the connection portion or portions of the tube of theoral adaptor could have an elbow so as to direct its end toward the topof the person's head instead of toward its side.

The hose or hoses connecting the oral adaptor to the respirator areadvantageously long enough to enable movement of the person during sleepand also to enable locating the respirator away from the person's bed.For example, the overall length of the hose or hoses may be preferablyat least six feet.

Advantages of the head appliance according to the present inventioninclude a very tight seal around the mouth without application of highpressure or strong forces which could irritate or damage the skin or beuncomfortable. Rather, a perfect seal is obtained “passively” byconforming the lips around the tube between the peripheral flange andthe sealing element, with the air pressure providing the force necessaryto press the lips against the sealing element. This is obtained byadjusting the forces applied by the straps so that the sealing elementapplies a relatively low pressure force on the lips toward the flangeand a relatively high shear force on the lips toward the tube. As aresult, the lips are sealed against the tube and ballooning of the lipsby the formation of air pockets between the lips and the flange areeffectively prevented without damaging the skin on and around the lips.

Particular embodiments of the present invention include one or more ofthe following: the elements in contact with the skin are soft; otherthan the exhalation port, no element of the head appliance is rigid—sothe sleeper can roll over without a rigid component creating leveragethat could create leaks; the head appliance is compact; no elementextends away from the head significantly farther from the nose, whichgives more freedom of movement without leverage on the mouthpiece ornasal seal, i.e., without creating unintentional leaks. Accordingly, thehead appliance is very robust. Lubrication around the lips is notnecessary, unless the person desires additional sealing. Lubricants,such as petroleum jelly, may be helpful to form a seal in the nose.

CLOSURE

While preferred embodiments of the present invention have been shown anddescribed, it will be apparent to those skilled in the art that manychanges and modifications may be made without departing from theinvention in its broader aspects. For example, although each embodimentof the head appliance is described with one type of oral adaptor and onetype of nasal seal, numerous variations are possible such as an oraladaptor of one embodiment and a nasal seal of another embodiment, andthese variations are included within the scope of the invention. Inparticular, a person of the art will understand that one or severalfeatures of any of the described embodiment can be combined or appliedto another embodiment of the present invention. The appended claims areintended to include all such changes and modifications as fall withinthe true spirit and scope of the invention.

1. An oral adaptor for a CPAP (Continuous Positive Airway Pressure)device, comprising: an oral insert having a passage therein, comprisingan insertion portion to be inserted into a person's mouth and aconnection portion for connecting the oral insert to a CPAP respirator,and a sealing element to be placed on the person's mouth, wherein thesealing element comprises a flexible, elastic diaphragm such that theperson's lips form a seal on the oral insert.
 2. An oral adaptoraccording to claim 1 wherein the oral adaptor comprises a tube adaptedfor passing through the lips of a person; and further comprising a strapattached to the tube.
 3. An oral adaptor as claimed in claim 1,comprising at least one holding strap to be placed around the person'shead for maintaining the sealing element on the person's mouth.
 4. Anoral adaptor as claimed in claim 3, wherein the sealing element is adiaphragm and wherein a foam pad is placed between the diaphragm and theat least one holding strap.
 5. An oral adaptor as claimed in claim 1,wherein the diaphragm is integral with the oral insert.
 6. An oraladaptor as claimed in claim 1, wherein the sealing element faces aflange of the insertion portion when the oral adaptor is applied to theperson's mouth.
 7. An oral adaptor as claimed in claim 1, furthercomprising an exhalation port.
 8. An oral adaptor to be applied to aperson's mouth, comprising: a tubular portion having an insertion end tobe inserted in a person's mouth and a connection end to be connected toa source of positive pressure, and a first surface which faces an innerside of a person's lips, and a second surface which faces an outer sideof the person's lips, when the oral adaptor is applied to the person'smouth, wherein the second surface is made of a more flexible materialthan the first surface, such that the person's lips are conformedbetween the second surface and at least one of the tubular portion andthe first surface when a positive pressure is created inside the mouthto form a seal around the oral adaptor.
 9. An oral adaptor as claimed inclaim 8, wherein at least one of the first surface and the secondsurface is made of flexible material.
 10. An oral adaptor as claimed inclaim 6, wherein the sealing element is made of a more flexible materialthan the flange.
 11. An oral adaptor as claimed in claim 6, wherein thesealing element is made of an elastic material.
 12. An oral adaptor asclaimed in claim 8, wherein the first surface is carried by a flange tobe placed between the person's teeth and lips around the insertion endof the tubular portion.
 13. An oral adaptor as claimed in claim 12,wherein the second surface is carried by a sealing element to be placedon the person's lips around the tubular portion.
 14. An oral adaptor asclaimed in claim 13, further comprising an exhalation port.
 15. A nasalseal comprising two curved pieces to be placed on respective exteriorsides of a person's nose, the curved pieces being connected to eachother so as to leave a space between them for the person's nose, whereina holding strap is attached to the nasal seal for application on theperson's nose; and wherein the curved pieces are connected to each otherby an elastic connection member so that an adjustable space for the noseis defined between the curved pieces.
 16. A nasal seal as claimed inclaim 15, wherein the curved pieces are rollers rotatable aroundrespective axes, the axes being connected to each other so as to leave aspace between the rollers for the person's nose.
 17. A nasal seal asclaimed in claim 16, wherein ends of the holding strap are attached tothe respective rollers at a distance from their respective rotationaxes, so that a degree of rotation of the rollers can adjusted byadjusting the strap.
 18. A nasal seal as claimed in claim 17, whereinthe rollers are cylindrical and wherein the ends of the holding strapare attached to the cylindrical rollers such that the rollers rotate inopposite directions when the strap is pulled.
 19. A head appliance for aCPAP device, comprising: a mouthpiece having an insertion portion to beinserted in a person's mouth and a connection portion to be connected toa CPAP respirator, a connection tube having an end connected to theconnection portion of the mouthpiece, a head strap to be placed over apersons' head, and a hose support attached to the head strap forsupporting the connection hose; and wherein the connection portion, thehead strap, and the hose support are adapted such that, when applied toa person's head, project from the head by substantially no more than thelength of a nose.
 20. A head appliance for a CPAP device, comprising: anoral adaptor according to claim 1, and a nasal seal.
 21. A headappliance for a CPAP device, comprising: an oral adaptor according toclaim 8, and a nasal seal.
 22. A CPAP device, comprising: a CPAPrespirator, and a head appliance according to claim
 20. 23. A CPAPdevice, comprising: a CPAP respirator, and an oral adaptor according toclaim
 1. 24. A method for treating symptoms of sleep apnea in a person,comprising: inserting an insertion portion of an oral insert in theperson's mouth, applying a sealing element on the person's mouth so thatthe person's lips form a tight seal with the insertion portion of theoral insert, and connecting the oral insert to a source of positivepressure.
 25. A method for treating symptoms of sleep apnea in a person,comprising: providing an oral insert comprising a tube; inserting aninsertion portion of an oral insert in the person's mouth such that afirst surface of the insertion portion faces an inner side of theperson's lips, and a tube passes through the lips, and applying asealing element on the person's mouth such that a second surface of thesealing element faces an outer side of the person's lips, and such thata relatively high shear force is applied to the lips toward the tube sothat the lips form a tight seal with the tube, and connecting the oralinsert to a source of positive pressure.
 26. A nasal seal comprising tworollers to be placed on respective exterior sides of a person's nose,the rollers being connected to each other so as to leave a space betweenthem for the person's nose, wherein a holding strap is attached to thenasal seal for application on the person's nose; wherein the rollers arerotatable around respective axes, the axes being connected to each otherso as to leave a space between the rollers for the person's nose; andwherein ends of the holding strap are attached to the respective rollersat a distance from their respective rotation axes, so that a degree ofrotation of the rollers can be adjusted by adjusting the strap.
 27. Anasal seal as claimed in claim 26, wherein the rollers are cylindricaland wherein the ends of the holding strap are attached to thecylindrical rollers such that the rollers rotate in opposite directionswhen the strap is pulled.
 28. An head appliance according to claim 20wherein the oral adaptor comprises a tube adapted for passing throughthe lips of a person; and further comprising a diaphragm that isseparate from the tube.
 29. A nasal seal comprising two rollers to beplaced on respective exterior sides of a person's nose, the rollersbeing connected to each other so as to leave a space between them forthe person's nose, wherein the each roller has an axis and the rollersare connected such that the axes are substantially parallel when placedon the respective exterior sides of a person's nose; and wherein aholding strap is attached to the nasal seal for application on theperson's nose.
 30. A head appliance according to claim 20 furthercomprising a strap to maintain the diaphragm against the outer lips of aperson.
 31. A head appliance according to claim 30 wherein the strapcomprises an enlarged portion to be placed over the diaphragm andwherein the diaphragm is sufficiently large to extend above and belowthe enlarged portion.
 32. An oral adaptor according to claim 2 furthercomprising a second strap attached to a part of the oral adaptor.
 33. Anoral adaptor according to claim 32 wherein the diaphragm is integralwith or attached to the second strap.
 34. The head appliance of claim 30further comprising a pressure portion attached to the strap to maintainthe diaphragm against the outer lips of a person.
 35. A nasal sealaccording to claim 18 wherein each of the cylinders has an aperturetherethrough, and wherein an elastic band connects the cylinders.
 36. Amethod of scaling a person's nose, comprising the steps of: placing thenasal seal of claim 16 on the face of a person and rotating the rollersin opposite directions.
 37. A head appliance according to claim 20wherein the oral adaptor comprises a tube adapted for passing throughthe lips of a person; and further comprising a holding strap to beplaced around a person's head, wherein the holding strap is attached tothe tube.
 38. A head appliance according to claim 37 further comprisinga strap to maintain the diaphragm against the outer lips of a person.39. A head appliance according to claim 38 wherein the strap to maintainthe diaphragm against the outer lips of a person comprises an enlargedportion with a hole such that the strap can be passed over the tube andapplied against the diaphragm.
 40. A head appliance according to claim20 further comprising a jaw strap.
 41. A head appliance according toclaim 20 further comprising a pressure portion attached to a diaphragmstrap or a jaw strap.
 42. A head appliance according to claim 20 furthercomprising a head band and a hose support attached to the head band. 43.A head appliance according to claim 30 further comprising a pad disposedbetween the strap and the diaphragm.
 44. A head appliance according toclaim 20 further comprising an upper diaphragm strap and a lowerdiaphragm strap.
 45. A head appliance according to claim 20 wherein,when the head appliance is worn by a person, neither the connectionportion nor the sealing element extend away from the person's headsubstantially farther than the nose.
 46. A head appliance according toclaim 20 wherein the nasal seal comprises the nasal seal of claim 15.47. A head appliance according to claim 21 further comprising a jawstrap.
 48. A head appliance according to claim 21 wherein furthercomprising upper and lower straps to keep the sealing element in place.49. A head appliance according to claim 21 further comprising a headband and a hose support attached to the head band.
 50. A head applianceaccording to claim 21 wherein the oral adaptor comprises a tube adaptedfor passing through the lips of a person; and further comprising a strapattached to the tube.
 51. A head appliance according to claim 21 whereinthe oral adaptor comprises: a tubular portion having an insertion end tobe inserted in a person's mouth and a connection end to be connected toa source of positive pressure, and a first surface which faces an innerside of a person's lips, and a second surface which faces an outer sideof the person's lips, when the oral adaptor is applied to the person'smouth, wherein the second surface is made of a more flexible materialthan the first surface, such that the person's lips are conformedbetween the second surface and at least one of the tubular portion andthe first surface when a positive pressure is created inside the mouthto form a seal around the oral adaptor; wherein the first surface iscarried by a flange to be placed between the person's teeth and lipsaround the insertion end of the tubular portion; and wherein the secondsurface is carried by a sealing element to be placed on the person'slips around the tubular portion.
 52. A method according to claim 24further comprising the step of applying petroleum jelly in the spacebetween the sealing element and the insertion portion of the oralinsert.
 53. A method according to claim 24 wherein the elastic sealingelement is stretched to obtain a tighter seal with the lips.
 54. Amethod according to claim 24 wherein the oral insert comprises a tubeadapted for passing through the lips of a person and a holding strap tobe placed around a person's head, wherein the holding strap is attachedto the tube; further comprising the step of passing the strap around theperson's head.
 55. A method according to claim 54 wherein the oralinsert further comprises a flange further comprising a step of passing asecond strap around the person's head, wherein the second strap appliesa force that pushes the person's lips toward the tube and a force thatpushes the person's lips toward the mouth, wherein the force that pushesthe person's lips toward the tube is comparable to the force that pushesthe person's lips toward the mouth.
 56. A method according to claim 24further comprising a step of passing a jaw strap around the person'shead and around the person's chin.
 57. A method of sealing a person'snose comprising placing the nasal seal of claim 18 on a person's faceand pulling the holding strap.
 58. A method according to claim 57wherein the rollers close the person's nostrils primarily by applyingshear forces to the skin next to the base of the nose.
 59. A methodaccording to claim 24 further comprising passing a head band around theperson's head and passing a connection hose through a hose support thatis attached to the head band.
 60. A method according to claim 25 whereinthe oral insert comprises: a tubular portion having an insertion end tobe inserted in a person's mouth and a connection end to be connected toa source of positive pressure, and a first surface which faces an innerside of a person's lips, and a second surface which faces an outer sideof the person's lips, when the oral adaptor is applied to the person'smouth, wherein the second surface is made of a more flexible materialthan the first surface, such that the person's lips are conformedbetween the second surface and at least one of the tubular portion andthe first surface when a positive pressure is created inside the mouthto form a seal around the oral adaptor; wherein the first surface iscarried by a flange to be placed between the person's teeth and lipsaround the insertion end of the tubular portion; and wherein the secondsurface is carried by a sealing element to be placed on the person'slips around the tubular portion.
 61. The nasal seal of claim 16 whereinthe elastic connection comprises an elastic band that moves through anaperture in each roller.
 62. The nasal seal of claim 61, wherein therollers are rotatable around respective axes, the axes being connectedto each other so as to leave a space between the rollers for theperson's nose.
 63. The nasal seal of claim 62, wherein ends of theholding strap are attached to the respective rollers at a distance fromtheir respective rotation axes, so that a degree of rotation of therollers can adjusted by adjusting the strap.
 64. A nasal seal as claimedin claim 63, wherein the rollers are cylindrical and wherein the ends ofthe holding strap are attached to the cylindrical rollers such that therollers rotate in opposite directions when the strap is pulled.
 65. Thenasal seal of claim 62 wherein the rollers comprise a flexible material.